gresonitamab (AMG 910) / Amgen - LARVOL DELTA

A preclinical in vitro platform for evaluating the potency of bispecific T cell engagers in 2D and 3D models (AACR 2025) - "In this study in vitro assays were established to evaluate the tumor cell-killing and T cell activation of BiTEs, specifically using a claudin18.2-targeted BiTE AMG910 and the monoclonal antibody zolbetuximab. Target expression on tumor cells for claudin18.2 and AMG910/zolbetuximab binding to tumor and T cells was evaluated via flow cytometry. Successful in vitro assays were developed for preclinical BiTEs testing. 2D co-cultures efficiently assess direct tumor cell killing and T cell activation mediated by antibody treatments. Additionally, 3D organoid co-cultures offered a more physiologically relevant setup, mimicking the tumor microenvironment and representing patient diversity."

Preclinical • Oncology • CD69 • CLDN18 • GZMB • IFNG • IL2RA

An anti-claudin 18.2/CD3 bispecific antibody for the treatment of claudin 18.2 positive gastric cancer (AACR 2024) - "However, Zolbetuximab (IMAB362) has successfully reached the Phase III end point, indicating positive clinical outcomes and establishing CLDN18.2 as a promising cellular and antibody therapeutic option. In conclusion, the novel anti-CLDN18.2 × anti-CD3 bispecific antibody LNF2007 demonstrates similar efficacy to AMG 910 and AZD5863 and is safer. LNF2007 provides a promising therapy for claudin 18.2-positive cancer patients.Taishan Industry Leading Talents Project of Shandong Province was a sponsor of this research."

IO biomarker • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: Amgen | Completed ➔ Terminated; Business Decision

Trial termination • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

CLDN18.2 BiTE Engages Effector and Regulatory T Cells for Antitumor Immune Response in Preclinical Models of Pancreatic Cancer. (PubMed, Gastroenterology) - "Our data suggest that BiTE molecule treatment converts Treg function from immunosuppressive to immune enhancing, leading to antitumor activity in immunogenically "cold" tumors."

IO biomarker • Journal • Preclinical • Gastric Cancer • Gastrointestinal Cancer • Hepatology • Immune Modulation • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CLDN18

Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Amgen | Active, not recruiting ➔ Completed | Trial completion date: Nov 2023 ➔ Jun 2022 | Trial primary completion date: Nov 2023 ➔ Jun 2022

Trial completion • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

QLS31905, an anti-claudin 18.2/CD3 bispecific antibody for claudin 18.2-positive gastric cancer (AACR 2022) - "Anti-claudin 18.2 antibody IMAB362 has achieved remarkable success in the latest clinical trials. Overall, these data suggested that QLS31905 has similar efficacy to AMG 910 and is safer. QLS31905 may be an effective and clinically valuable treatment for patients with claudin 18.2-positive gastric cancer."

Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18 • CLDN8

Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1; N=16; Active, not recruiting; Sponsor: Amgen; N=70 ➔ 16; Trial completion date: Oct 2025 ➔ Nov 2023; Trial primary completion date: Oct 2025 ➔ Nov 2023; Recruiting ➔ Active, not recruiting

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

[VIRTUAL] Phase I study evaluating safety and tolerability of AMG 910, a half-life extended bispecific T cell engager targeting claudin-18.2 (CLDN18.2) in gastric and gastroesophageal junction (G/GEJ) adenocarcinoma (ESMO 2020) - P1 | "Trial design Key eligibility criteria include patients aged ≥18 years with histologically or cytologically confirmed metastatic or locally advanced unresectable CLDN18.2-positive G/GEJ adenocarcinoma, ineligible for curative surgery who are refractory to or have relapsed following ≥2 prior lines that included a platinum, a fluoropyrimidine, a taxane or irinotecan, and an approved vascular endothelial growth factor receptor antibody or tyrosine kinase inhibitor. Funding: Amgen Inc. Clinical trial identification: NCT04260191 - Feb 7, 2020."

Clinical • P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology

Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Amgen; Trial completion date: Jan 2026 ➔ Sep 2025; Trial primary completion date: Jan 2026 ➔ Sep 2025

Clinical • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Amgen Reports First Quarter 2021 Financial Results (PRNewswire) - "The following programs continue to enroll patients in dose escalation studies: (i) BiTE® molecules AMG 330 and AMG 427, targeting CD33 and fms-like tyrosine kinase 3 (FLT3), respectively, for acute myeloid leukemia; (ii) AMG 176, a small molecule inhibitor of myeloid cell leukemia 1 (MCL-1) for hematologic malignancies; (iii) HLE BiTE molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2 (CLDN18.2), respectively, for gastric and gastroesophageal junction cancer; (iv) AMG 509, a bivalent T-cell engager XmAb® 2+1 antibody targeting six transmembrane epithelial antigen of the prostate 1 (STEAP1) for prostate cancer. AMG 256, a bifunctional interleukin-21 agonist for PD-1 positive solid tumors."

Enrollment status • Acute Myelogenous Leukemia • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor

Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Amgen; Trial completion date: Jun 2024 ➔ Aug 2025; Trial primary completion date: Jun 2024 ➔ Aug 2025

Clinical • Trial completion date • Trial primary completion date • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Amgen; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

[VIRTUAL] Preclinical evaluation of BiTE®immune therapy targeting MUC17 or CLDN18.2 for gastric cancer (AACR-II 2020) - "In contrast, treatment with AMG 910 led to direct cell killing of CLDN18.2-expressing gastric mucosal cells in NHP, a finding which was fully reversible once treatment was stopped. AMG 199 and AMG 910 may offer the potential to improve outcomes in advanced gastric patients worldwide."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of AMG 910 in Subjects With CLDN18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1; N=70; Not yet recruiting; Sponsor: Amgen

Clinical • New P1 trial